a study of pembrolizumab/vibostolimab (mk-7684a) in relapsed/refractory hematological malignancies (mk-7684a-004, keyvibe-004)

Conditions: Hematological Malignancies

Summary: the purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (mk-7684a) in hematological malignancies. this study will also evaluate the overall response rate (orr), the duration of response (dor), and disease control rate (dcr) following administration of pembrolizumab/vibostolimab. in addition, this study will characterize pharmacokinetic (pk) profile of vibostolimab (mk-7684).


Eligibility criteria:
inclusion criteria - have confirmed relapsed/refractory classic hodgkins lyphoma (chl), primary mediastinal b-cell lymphoma (pmbcl), follicular lymphoma (fl), diffuse large b-cell lymphoma (dlbcl) or non-hodgkins lymphoma (nhl), or multiple myeloma (mm). for pmbcl, dlbcl, fl, and mm: - must be relapsed or refractory to car-t-cell therapy or unable to receive it. for dlbcl and nhl: - must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease. for nhl: - participants with mantle cell lymphoma (mcl) must have received prior bruton's tyrosine kinase inhibitor therapy. all participants: * have measurable disease. * have adequate organ function. * participants who are hepatitis b surface antigen (hbsag) positive are eligible if they have received hepatitis b (hbv) antiviral therapy for at least 4 weeks and have undetectable hbv viral load before allocation. * must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment. * female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of non child-bearing potential (woncbp) or is a woman of childbearing potential (wocbp) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle. exclusion criteria for dlbcl and nhl: - has lymphoplasmacytic lymphomas, waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), burkitt (-like) lymphoma, mature t cell and nk cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms. for mm: * has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance. * has a history of primary amyloidosis, hyperviscosity or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). * has known prior or current central nervous system (cns) involvement. for epstein barr virus (ebv) positive dlbcl: - associated with a solid organ transplant. for all participants: * a wocbp who has a positive urine pregnancy test within 72 hours before study intervention allocation. * has clinically significant cardiovascular disease within 12 months from first dose of study intervention. * has a history of a second malignancy. * any pmbcl participants that require the use of urgent cytoreductive therapy. * if the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention. * has received prior radiotherapy within 2 weeks of start of study intervention. * has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. * has a known severe hypersensitivity to mk-7684a, vibostolimab or pembrolizumab and/or any of its excipients. * has a known history of human immunodeficiency virus (hiv) infection. * has an active autoimmune disease that has required systemic treatment in past 2 years. * has an active infection requiring systemic therapy. * has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment. * has dual active hbv infection (hbsag (+) and /or detectable hbv dna) and hepatitis c (hcv) infection (anti-hcv ab (+) and detectable hcv rna) at study entry.. * has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.